BACKGROUND: AU5822 Automated Clinical Chemistry Analyzer (Beckman Coulter, USA) is a fully automated analytical platform designed for the analysis of general chemistry, specific serologic proteins, therapeutic drug monitoring, and drug abuse testing. AU5822 is a high-throughput system that can process up to 5,800 tests per hour and is easy to maintain. In this study, we evaluated the performance of AU5822 on 31 analytes. METHODS: The precision, linearity, correlation, and sample carryover of 31 analytes were evaluated in accordance with the guidelines of the Clinical Laboratory Standards Institute (CLSI). Lyphochek (Bio-Rad Laboratories Inc., USA), Liquichek (Bio-Rad Laboratories Inc.), Validate (Marine Standard Company, USA), and patient sera were used in the analysis. For the correlation study, we carried out a comparison of AU5822 and Cobas 8000 Modular Analyzer (Roche, Switzerland). RESULTS: The coefficients of variation of all samples showed values below 5%. The coefficient of determination (R2) was > or =0.99, with linearity in the clinically important range. The comparison with Cobas 8000 showed a good correlation, with a correlation coefficient of >0.975 for all of the analytes, excluding sodium that had a correlation coefficient of 0.9641. The test values of percentage sample carryover were less than 0.89%. CONCLUSIONS: AU5822 performed well in terms of precision, linearity, comparison, and sample carryover in the established assays for 31 analytes. Therefore, Beckman Coulter AU5822 Automated Clinical Chemistry Analyzer is expected to be useful for routine chemistry analysis in hospitals with large test volumes.
Chemistry ; Chemistry, Clinical* ; Drug Monitoring ; Humans ; Sodium ; Statistics as Topic ; Substance Abuse Detection

Drug Monitoring ; statistics & numerical data ; Drugs, Chinese Herbal ; pharmacokinetics ; pharmacology ; Humans ; Research Design ; Serum ; chemistry

We studied the prevalence, type and severity of vigabatrin (VGB)-attributed visual field defects (VFDs), and used these data to assess the associated risk factors in pediatric patients. Medical records were retrospectively reviewed for 67 pediatric patients who received VGB alone or in combination with other antiepileptic drugs, and who had undergone visual field examinations using a Humphrey visual field analyzer. Of the 67 patients, 15 had VGB-attributed VFDs: 13 had nasal arcuate type, 1 had nasal and temporal constricted type and 1 had nasal constricted type. In terms of severity, 7 patients had Grade I VGB-attributed VFDs, 5 had Grade II, 2 had Grade III, and 1 had Grade IV. Although there were no significant differences between the VFD and non-VFD groups with regards to all tested parameters, there were no cases of VGB-attributed VFDs in patients with total treatment durations <2 yr and cumulative doses <10 g/kg. In conclusion, the prevalence of VGB-attributed VFDs in VGB-treated pediatric epilepsy patients was 22%. The high frequency of VGB-attributed VFDs indicates that physicians should inform all patients of this risk prior to VGB treatment and perform periodic visual field examinations.
Visual Fields/drug effects ; Vision Disorders/*chemically induced ; Vigabatrin/adverse effects/*therapeutic use ; Time Factors ; Risk Factors ; Retrospective Studies ; Male ; Humans ; Female ; Epilepsy/*drug therapy ; Drug Therapy, Combination ; Drug Monitoring/statistics & numerical data ; Child ; Anticonvulsants/adverse effects/*therapeutic use ; Adult

PURPOSE: We conducted a prospective single-center study to evaluate the possibility of discontinuation of dutasteride after combination therapy with an alpha blocker for benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: We prospectively treated BPH patients with an alpha blocker and dutasteride (0.5 mg/d). Patients who had been treated with alpha blockers against BPH for more than 2 months were eligible, and 20 patients were included in the study. After 6 months of combination therapy, dutasteride was discontinued. Patients were followed for 12 months after cessation. Prostate volume, intraprostatic architecture determined by transrectal ultrasound, peak urinary flow rate, postvoid residual urine volume, and the serum prostate-specific antigen level were evaluated every 6 months, and the International Prostate Symptom Score and overactive bladder symptom score (OABSS) every 3 months. Patients were allowed to restart dutasteride during the follow-up period according to their desire. RESULTS: Twelve patients (12/20, 60%) restarted the combination therapy from 6 to 12 months into the follow-up period. For patients who restarted dutasteride, the prostate volume and OABSS had increased and worsened after discontinuation, respectively. A visible transition zone with a clear border on transrectal ultrasound at baseline and regrowth of the prostate after discontinuation of dutasteride were risk factors for restarting the therapy (Mann-Whitney U test: p=0.008, p=0.017). CONCLUSIONS: Prostatic enlargement after discontinuation of dutasteride differs among patients. Rapid regrowth of the prostate leads to deterioration of storage symptoms and a tendency to restart dutasteride. Baseline intraprostatic architecture may be a predictive factor for whether the patient is a good candidate for discontinuation.
5-alpha Reductase Inhibitors/administration & dosage/adverse effects ; *Adrenergic alpha-Antagonists/administration & dosage/adverse effects ; Aged ; Drug Monitoring ; Drug Therapy, Combination/methods ; *Dutasteride/administration & dosage/adverse effects ; Follow-Up Studies ; Humans ; Japan ; Male ; Middle Aged ; Organ Size ; Prospective Studies ; *Prostate/drug effects/pathology/ultrasonography ; Prostate-Specific Antigen/analysis ; *Prostatic Hyperplasia/drug therapy/pathology ; Secondary Prevention/methods/statistics & numerical data ; Treatment Outcome ; Withholding Treatment

Hepatic adverse drug reactions (ADRs) to certain drugs may differ within each country, reflecting different patterns of prescription, socioeconomic status, and culture. The purpose of this study was to assess the suspected cause of hepatic ADRs using the spontaneously reported pharmacovigilance data from Korea. A total of 9,360 spontaneously reported adverse drug events (ADEs) from nine Pharmacovigilance Centers were analyzed. Risk of hepatic ADEs was assessed by calculating the reporting odds ratio (ROR). Of the 9,360 cases, 567 hepatic ADEs were reported. The most frequently prescribed drug classes inducing hepatic ADEs were anti-tuberculotics, cephalosporins, valproic acids, penicillins, quinolones, non-steroidal anti-inflammatory drugs (NSAIDs), anti-viral agents, and statins. ROR values were especially high in anti-tuberculosis drugs, systemic antifungal drugs for systemic use, anti-epileptics, propylthiouracil, and herbal medicines. Underlying diseases such as tuberculosis (6.9% vs 0.9%), pneumonia (4.9% vs 1.7%), intracranial injury including skull fracture (4.5% vs 0.9%), HIV (3.4% vs 0.4%), subarachnoid hemorrhage (2.8% vs 0.5%), and osteoporosis (2.4% vs 1.4%) were significantly more common in hepatic ADE group. In conclusion, anti-infective drugs, anti-epileptics, NSAIDs and statins are the most common suspects of the spontaneously reported hepatic ADEs, in Korea. Careful monitoring for such reactions is needed for the prescription of these drugs.
Adult ; *Adverse Drug Reaction Reporting Systems/statistics & numerical data ; Aged ; Anti-Infective Agents/adverse effects ; Anti-Inflammatory Agents, Non-Steroidal/adverse effects ; Anticonvulsants/adverse effects ; Drug Monitoring ; Drug-Induced Liver Injury/*epidemiology/*etiology ; Female ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects ; Male ; Middle Aged ; Odds Ratio ; Pharmacovigilance ; Republic of Korea/epidemiology ; Risk Factors

PURPOSE: Angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) are associated with a decreased incidence of new-onset diabetes mellitus (NODM). The aim of this study was to compare the protective effect of ACEI versus ARBs on NODM in an Asian population. MATERIALS AND METHODS: We investigated a total of 2817 patients who did not have diabetes mellitus from January 2004 to September 2009. To adjust for potential confounders, a propensity score matched (PSM) analysis was performed using a logistic regression model. The primary end-point was the cumulative incidence of NODM, which was defined as having a fasting blood glucose > or =126 mg/dL or HbA1c > or =6.5%. Multivariable cox-regression analysis was performed to determine the impact of ACEI versus ARB on the incidence of NODM. RESULTS: Mean follow-up duration was 1839+/-1019 days in all groups before baseline adjustment and 1864+/-1034 days in the PSM group. After PSM (C-statistics=0.731), a total 1024 patients (ACEI group, n=512 and ARB group, n=512) were enrolled for analysis and baseline characteristics were well balanced. After PSM, the cumulative incidence of NODM at 3 years was lower in the ACEI group than the ARB group (2.1% vs. 5.0%, p=0.012). In multivariate analysis, ACEI vs. ARB was an independent predictor of the lower incidence for NODM (odd ratio 0.37, confidence interval 0.17-0.79, p=0.010). CONCLUSION: In the present study, compared with ARB, chronic ACEI administration appeared to be associated with a lower incidence of NODM in a series of Asian cardiovascular patients.
Adult ; Aged ; Angiotensin Receptor Antagonists/*therapeutic use ; Angiotensin-Converting Enzyme Inhibitors/*therapeutic use ; Asian Continental Ancestry Group/*statistics & numerical data ; Blood Glucose/analysis ; Diabetes Mellitus/*diagnosis/*epidemiology ; Dose-Response Relationship, Drug ; Drug Monitoring/methods ; Female ; Follow-Up Studies ; Humans ; Hypertension/*drug therapy ; Incidence ; Kaplan-Meier Estimate ; Logistic Models ; Male ; Middle Aged ; Multivariate Analysis ; Propensity Score ; Republic of Korea/epidemiology ; Risk Factors